Infant Sleep Hygiene Counseling Trial

Summary

This study will evaluate the efficacy of an intervention to improve quality and duration of self-regulated nighttime sleep (the amount of time the child maintains a combination of uninterrupted sleep, quiet wakefulness, and re-initiation of sleep without parental intervention).

Conditions

• Sleep

Interventions

BEHAVIORAL

Sleep hygiene counseling

The mothers of the eligible infants will be visited at home and will be invited to participate at the study. To those who sign the Consent Form (CF) a following visit will be scheduled to within 5 days. Between CF signature and the 5-day visit, the enrolled children will use an actigraph-device in the leg and the mothers will fill out a sleep diary registering the times of the day the child is asleep, awake, napping, and feeding. At the 5-day visit the child allocation in the trial (intervention or control group) will be uncovered and the sleep recommendations will be delivered to mothers in the intervention group. Phone calls on days 6 and 7 and a home visit on day 8 will be paid to support mothers for possible difficulties in implementing the recommendations.

Sponsors & Collaborators

• University of Toronto

  collaborator OTHER

• University of Sao Paulo

  collaborator OTHER

• Hospital Nossa Senhora da Conceicao

  collaborator OTHER

• University of Oxford

  collaborator OTHER

• Federal University of Pelotas

  lead OTHER

Principal Investigators

• Bianca Del Ponte, PhD · Federal University of Pelotas

• Suélen Cruz, PhD · Federal University of Pelotas

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

3 Months

Max Age

4 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-10-31

Primary Completion

2016-05-31

Completion

2016-05-31

Countries

• Brazil

Study Locations